News tagged with 'Drug Approvals'

Two major shakeups at the Food and Drug Administration may be signs of how the agency is remaking itself to become more pro-consumer and less friendly to the industries it tries to regulate.

Giving regulators the authority to impose a two-year ban on consumer ads when a drug first reaches the market is a priority for Rep. Henry Waxman as he prepares to take the reins as Chairman of the Committee on Energy and Commerce in January.

Medicaid has paid more than $200 million since 2004 for unapproved drugs. These drugs pose a public health concern and many have been linked to several of deaths. 2008 data is not yet available, but unapproved drugs are still being sold.

More than half of clinical trials don't see the light of day, even five years after the drug hits the market, according to a new study by the University of California. That makes it difficult for consumers and doctors to stay on top of research and raises questions about what's being hidden.

Not to scare off investors- the FDA will send kinder, gentler letters to drug makers who submit a new drug for approval.